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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Methadone
510(k) Number K884968
Device Name TDX METHADONE ASSAY
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Applicant Contact MARY ZORC
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent Contact MARY ZORC
Regulation Number862.3620
Classification Product Code
DJR  
Date Received11/30/1988
Decision Date 12/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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